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The Liberty Valve is intended to allow individuals in a wheelchair to empty their own urine collection leg bag, which may be connected to either an indwelling or non-indwelling catheter, provided the individual possesses the ability to make gross arm and hand movements.

Device Description

The Liberty Valve consists of a switch box, a solenoid valve with electrical connection, a fuse, battery leads with wiring, and tubing with the necessary connections for attachment to the leg bag and valve. The device is to be mounted to the wheelchair permanently with the clamps and wire ties provided. The switch box regulates the power from the battery which opens the solenoid valve the urine collection leg bag to drain.

AI/ML Overview

Here's an analysis of the provided text, focusing on acceptance criteria and the study proving device performance:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria / Performance Metric	Acceptance Criteria (Implicit)	Reported Device Performance
Electrical Stability/Current Leaks	No potential (relative to negative terminal) and no current leaks should be exhibited in a worst-case scenario (supersaturated salt water solution). Absence of electrical activity in the solution should confirm electrical stability.	Tested in a supersaturated salt water solution for 2.5 hours with continuous flushing. Results: No potential exhibited and no current leaks (0 A, 0 V) at 3, 13, 30, and 150 minutes, both in the solution and on the surface. This result was attributed to the use of a septum and o-ring at the valve/connector interface, confirming electrical stability.
Drainage Time	The valve should effectively drain a urine collection bag. (Implicitly, within a reasonable timeframe, given the comparison to existing devices).	Bench Testing: - At 0 °C: 1 minute 53 seconds to drain 500 mL. - At 23 °C: 1 minute 49 seconds to drain 500 mL. - At 70 °C: 1 minute 45 seconds to drain 500 mL. All tests drained 500 mL from a urine collection bag held ten inches above the valve in less than two minutes.
Operating Temperature Range	The device should operate effectively across a suitable temperature range.	Tests conducted at 0 °C, 23 °C, and 70 °C showed the valve required less than two minutes to drain 500 mL at all these temperatures. Recommended: Use at temperatures between 0 °C and 70 °C.

Note regarding Acceptance Criteria: The provided document does not explicitly state numerical acceptance criteria for current leaks (e.g., "current leaks must be < X mA"). However, the reported performance of "0 A" and "0 V" clearly meets an implied criterion of no detectable leakage. Similarly, for drainage time, the "less than two minutes" performance is implicitly the successful criterion based on the testing.

2. Sample Size Used for the Test Set and the Data Provenance

Sample Size for Electrical Stability: Not explicitly stated as a "sample size" in the conventional sense (e.g., number of devices tested). The text describes testing "the Liberty Valve" in a single worst-case scenario. It implies a single device or a representative unit was subjected to the described electrical test.
Sample Size for Bench Testing (Drainage Time): Not explicitly stated. The text describes "Tests were conducted" at different temperatures, implying a single device or representative unit was tested at each temperature.
Data Provenance: The studies described ("worst case scenario for possible current leaks" and "Bench Testing") were conducted internally by Cleveland Medical Devices Inc. for the purpose of this 510(k) submission. The data is retrospective in the sense that it was generated prior to the submission, but it's not from a clinical trial or patient data.
Country of Origin: United States (Cleveland Medical Devices Inc., Cleveland, Ohio).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

Not applicable. The studies performed (electrical stability and drainage time) are engineering/bench tests of the device's physical properties and functionality, not diagnostic or interpretive studies requiring expert human assessment for ground truth. The "ground truth" here is the objective measurement of current, voltage, and time using laboratory equipment.

4. Adjudication Method for the Test Set

Not applicable. As stated above, these were objective physical measurements, not observational or interpretive assessments that would require adjudication.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

No, an MRMC comparative effectiveness study was not done. This device is a mechanical urine drainage valve, not an AI-powered diagnostic or assistive tool for human readers.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done

Not applicable. This is a hardware device, not an algorithm.

7. The Type of Ground Truth Used

Objective Physical Measurements / Engineering Specifications:
- For electrical stability: Measured current (A) and voltage (V) in a controlled environment. The "ground truth" was the absence of detectable electrical activity.
- For drainage time: Measured time (min) to drain a specified volume (500 mL) under controlled conditions. The "ground truth" was either the actual time taken or whether it met the "less than two minutes" implicit criterion.

8. The Sample Size for the Training Set

Not applicable. This device does not involve a "training set" in the context of machine learning or AI.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As stated above, there is no "training set" for this type of device.

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